Drug recall
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed…
FDA recall event 95701 · Class II · Noven Pharmaceuticals Inc
Key facts
| Event ID | 95701 |
|---|---|
| Recall numbers | D-0055-2025 |
| Recalling firm | Noven Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). |
| Initiation date | Oct 31, 2024 |
| Report date | Nov 27, 2024 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 1000222037 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: